TEST KIT, INFLUENZA +B
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The contract is for a diagnostic test kit designed for the qualitative detection of influenza A and B antigens directly from nasal swabs, nasal washes, or nasal aspirates, providing results within 10 minutes. Each kit contains 25 tests and is intended as an aid in the rapid differential diagnosis of acute influenza infections. The product must be stored at room temperature between 59°F and 86°F and has a non-extendable shelf life of 24 months, with no more than three months allowed to have elapsed from the date of manufacture to the date of delivery to the government. All packaging must comply with commercial standards and the Medical Marking Standard No. 1, superseding MIL-STD-129, and must include clear labeling of the date of manufacture, expiration date, and contract or lot number in accordance with MMS1C. The item is designated as a Type I (Code M) medical supply under RS016 requirements and is subject to hazardous communication standards under OSHA’s revised Hazard Communication Standard, requiring suppliers to submit Safety Data Sheets and compliant labels consistent with 29 C.F.R. 1910.1200 prior to contract award. Employee training on the new SDS and labeling requirements is mandatory. The unit of issue is one kit containing 25 tests, with a delivery requirement of 20 days after order and a federal NSN of 6550-01-531-2897 under solicitation SPE2DS-26-T-266B, issued by the Department of Defense’s Medical Supply Chain.
General Info
Agency
NAICS
Place of Performance
UNIT 100474 BOX 1, FPO, AP, 96694, USSet-Aside
Documents
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Timeline
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Organization & Contact Information
Full Description
TEST KIT,INFLUENZA A+B TEST
FEATURES QUALITATIVE DETECTION OF INFLUENZA TYPE A AND TYPE B
ANTIGENS DIRECTLY FROM NASAL SWAB, NASAL WASH AND/OR NASAL ASPIRATE
SPECIMENS. TEST IS INTENDED AS AN AID IN THE RAPID DIFFERENTIAL
DIAGNOSIS OF ACUTE INFLUENZA TYPE A AND TYPE B VIRUS INFECTION; 25 TESTS
PER KIT; RESULTS IN 10 MINUTES; STORAGE AT ROOM TEMPERATURE 59°F TO 86°F
(15°C TO 30°C)
UNIT OF ISSUE: KT (25 TESTS PER KIT)
..
RA001: THIS DOCUMENT INCORPORATES TECHNICAL AND/OR QUALITY REQUIREMENTS
(IDENTIFIED BY AN 'R' OR AN 'I' NUMBER) SET FORTH IN FULL TEXT IN THE
DLA MASTER LIST OF TECHNICAL AND QUALITY REQUIREMENTS FOUND ON THE WEB
AT:
http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx http://www.dla.mil/HQ/Acquisition/Offers/eProcurement.aspx
FOR SIMPLIFIED ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE SOLICITATION ISSUE DATE OR THE AWARD DATE CONTROLS. FOR LARGE ACQUISITIONS, THE REVISION OF THE MASTER IN EFFECT ON THE RFP ISSUE DATE APPLIES UNLESS A SOLICITATION AMENDMENT INCORPORATES A FOLLOW-ON REVISION, IN WHICH CASE THE AMENDMENT DATE CONTROLS.
..
RD003, COVERED DEFENSE INFORMATION POTENTIALLY APPLIES
..
RP001: DLA PACKAGING REQUIREMENTS FOR PROCUREMENT
..
RQ011: REMOVAL OF GOVERNMENT IDENTIFICATION FROM NON-ACCEPTED SUPPLIES
..
APPLICABLE TO ALL MEDICAL ACQUISITIONS:
PACKAGING AND PACKING SHALL BE COMMERCIAL AS
SPECIFIED IN THE PROCUREMENT DOCUMENT.
EACH COMPLETE UNIT SHALL BE PROPERLY PACKAGED
IN A SUITABLE SEALED UNIT CONTAINER CAPABLE
OF PROTECTING THE CONTENTS FROM DAMAGE AND/OR
BREAKAGE.
UNITS SHALL BE PACKED IN SUITABLE COMMERCIAL
EXTERIOR (SHIPPING) CONTAINERS (EXPORT WHEN
NECESSARY) WHICH SHALL INSURE ACCEPTANCE AND
SAFE DELIVERY BY COMMON OR OTHER CARRIER, AT
THE LOWEST RATE, TO POINT OF DELIVERY CALLED
FOR IN THE CONTRACT OR ORDER.
MATERIAL MUST BE MARKED IAW MEDICAL MARKING
STANDARD NO. 1. THIS SUPERCEDES ALL REFERENCES
TO MIL-STD-129.
COPIES OF MEDICAL MARKING STANDARD NO. 1
(MMS NO. 1) MAY BE OBTAINED BY CONTACTING DLA
TROOP SUPPORT VIA EMAIL TO fssb@dla.mil. MMS NO. 1 IS ALSO AVAILABLE ONLINE AT: https://www.dla.mil/Logistics-Operations/Packaging/
SPE2DS-26-T-266B
SECTION B
..
RS016: Shelf-life requirement RS001 for a TYPE I (CODE M) item with a shelf life of 24 months (non-extendable) applies to this item.
SHALL HAVE A SHELF LIFE OF 24 MONTHS.
NOT MORE THAN 3 MONTHS SHALL HAVE ELAPSED FROM
DATE OF MANUFACTURE TO DATE OF DELIVERY TO THE
GOVERNMENT.
.
SHELF LIFE MARKINGS SHALL BE IN ACCORDANCE WITH
THE LATEST REVISION OF MMS1C.
. ALL LABELS SHALL INCLUDE:
DATE OF MANUFACTURE, EXPIRATION, OR RETEST DATE
CONTRACT NUMBER/LOT NUMBER.
..
RQ034: HAZARDOUS COMMUNICATION STANDARD NOTICE
Hazard Communication Standard Notice:
Effective June 1, 2015, Federal Standard No. 313-E, Material Safety Data, Transportation Data and Disposal Data for Hazardous Materials Furnished to Government Activities, establishes the requirement for preparation and submission of Safety Data Sheets (SDS) in lieu of Material Safety Data Sheets (MSDS) by suppliers who provide hazardous materials to government activities.
The Occupational Safety and Health Administration (OSHA) has modified its Hazard Communication Standard (HCS) to conform to the United Nations Globally Harmonized System of Classification and Labeling of Chemicals. As a result of this change, GSA revised Federal Standard No. 313-E requiring Safety Data Sheets for classifying chemicals and communicating the applicable information on labels.
In accordance with the revised standard after June 1, 2015:
1. Suppliers will be required to submit, to the contracting officer for review and approval prior to award, safety data sheets consistent with the requirements found at 29 C.F.R. 1910.1200 for hazardous materials delivered to the Government.
2. Suppliers will also be required to submit, to the contracting officer for review and approval prior to award, Hazardous Communication Standard (HCS) labels in accordance with 29 C.F.R. 1910.1200 requirements or current Consumer Product Safety Act (CPSA), Federal Hazardous Substance Act (FHSA) labels when subject to labeling requirements under those statutes. This product labeling is required for hazardous materials delivered to the Government.
3. Finally, suppliers must train their employees on the new safety data sheets, hazardous communication labels, and requirements of 29 C.F.R. 1910.1200.
For more information on SDS, refer to OSHAs website, available at:
https://www.osha.gov/law-regs.html
For information on 29 C.F.R. 1910.1200, refer to the below link:
https://www.osha.gov/dsg/hazcom/index.html .. ADEQUATE DATA FOR THE NSN/Part Number: 6550-01-531-2897 Quantity: 1 KT Purchase Request: 7017591762QTY: 1 Delivery: 20 days ADO
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